"Interactive Metronome Technology for Blast-Related Traumatic Brain Injury"

The design of this study will be a randomized, controlled trial of Interactive Metronome
(IM) treatment compared with treatment as usual in patients with moderate to mild Traumatic
Brain Injury (TBI) due to blast. The study will be conducted at the Evans Army Community
Hospital at Fort Carson, Colorado . Patients will be randomized to IM training, or to a
treatment as usual/wait-list control condition. Patients randomized to receive IM training
will complete 15 sessions consisting of approximately 2000 repetitions each. Patients
randomized to treatment as usual will be offered the opportunity to receive IM training
following the conclusion of the six month study period. Outcome assessment will focus on
phase lag and coherence of electroencephalogram (EEG) activity, which are
electrophysiological measures of cortical connectivity. Primary outcomes will also include
attention and memory functioning, which are measured prior to the start of treatment, one
week following the end of treatment and 6 months after treatment ends.

Interactive Metronome (IM) technology is a behavioral feedback operant conditioning
system.15 In biofeedback, physiological information is displayed to the patient but with IM
information about the patient's behavioral responses is provided to them. Below the
investigators provide a detailed description of the behavioral tasks and give some idea as
to the program's complexity and operation. IM technology takes advantage of each of the
above discussed factors related to neuroplastic processes and integrates them into a single
set of tasks that are designed to encourage integrated neuroplastic activity under
cognitively demanding circumstances. The computerized feedback is reliable, consistent,
timely, and directly correlated with motor output. The feedback is also presented in a rich
cognitive and sensory environment that combines instantaneous delivery of simultaneous
auditory and visual feedback following the motor response. This information aids the
preparation of the upcoming behavioral response. All of this feedback processing and
adjustment of behavioral responses must occur in just over a second (1.111 seconds) because
the default tempo for IM training is 54 beats per minute. This places a considerable
temporal demand upon the attentional, integration, decision making, inhibitory, and motor
output operators of the cortex, thereby increasing processing speed and efficiency over the
course of training.

Inclusion Criteria:

1. Blast-related traumatic brain injury patients at least 3 months post injury with
recovery to a Rancho los Amigos level 7 or 8 (alert and oriented).

2. Brain injury documented by at least one of the following:

i. loss of consciousness, post traumatic amnesia ii. alteration in mental status
(dazed/confused), and/or physical evidence of iii.trauma (MRI/CT
hemorrhage/contusion)

3. A diagnosis of Postconcussional Disorder or Mild Neurocognitive Disorder Due to a
General Medical Condition.

4. Military or Veteran beneficiary

5. Males and females aged 18-55

Exclusion Criteria:

1. Current/prior (last 6 months) unstable medical condition that could affect current
brain function (e.g. clear anoxic episode, cardiac arrest, current uncontrolled
diabetes)

2. Status post craniectomy prior to cranioplasty (must be 90 days post cranioplasty
without surgical complication)

3. Prior History of moderate to severe TBI (not including present injury).

4. Current (last 3 months) active suicidal or homicidal ideation or intent.

5. Current (last month) drug/alcohol abuse or dependence as determined by a score of 5
or higher on the Alcohol Use Disorders Identification Test Consumption (AUDIT-C)

6. Use of benzodiazepine or narcotic medications.

7. Participation in a concurrent drug or treatment trial

8. Must be physically able to complete the treatment tasks (including sensory
functions).